SGLT2 Inhibition in Hemodialysis (DAPA-HD)
- Conditions
- Cardiovascular OutcomeTherapeutic area: Diseases [C] - Cardiovascular Diseases [C14]
- Registration Number
- EUCTR2021-000733-14-AT
- Lead Sponsor
- Medical University of Vienna
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 220
•Age =18 years
•Maintenance hemodialysis 3×/week for = 3 months and =5 years
•BMI < 45 kg/m2 and stable weight (± 5 kg) over the preceding three months
•Signed informed consent
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 110
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 110
•Study specific:
oHypersensitivity or Intolerance of SGLT2 inhibitors
oParticipation in another clinical trial
•Medical condition specific:
oHistory of diabetic ketoacidosis
oLife expectancy < 1 year
oInterventricular septum width = 11 mm
oSevere valvular heart disease
oSubstance abuse
oHistory of Type 1 diabetes mellitus
oScheduled kidney transplant from a living donor
oOther significant disease or pathology, that might predispose that patient to an unacceptable risk or interferes with the study in the opinion of the investigator.
oAcute coronary syndrome during the last 30 days
•Existing treatments with
oSGLT2i within the last 6 months
•Female specific:
oChild bearing potential & unwilling / unable to use an acceptable method to avoid pregnancy for the entire study (estrogen and/or progesterone treatment).
oPregnancy
oBreast feeding
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
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